FDA.reportPublic FDA data

Emvita 28

Product NDC
66343-115
11-digit product format
663430115
Labeler code
66343
Product ID
66343-115_28178d78-d696-c6eb-e063-6394a90a4f8b
Type
HUMAN OTC DRUG
Nonproprietary name
Cerebrum, Helleborus niger, Hyoscyamus niger, Mandragora
Dosage form
LIQUID
Route
ORAL
Labeler
RUBIMED AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-12-23
Substance
HELLEBORUS NIGER ROOT; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA CEREBRUM; SUS SCROFA PITUITARY GLAND
Active strength
18; 800; 21; 21 [hp_M]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emvita 28
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELLEBORUS NIGER ROOT18 [hp_M]/60mL
MANDRAGORA OFFICINARUM ROOT800 [hp_C]/60mL
SUS SCROFA CEREBRUM21 [hp_X]/60mL
SUS SCROFA PITUITARY GLAND21 [hp_X]/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii608DGJ6815, I2XCB174VB, 4GB5DQR532, L0PFEMQ1DT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66343-115-60Emvita 2860 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66343-115EMVITA 28 (CEREBRUM, HELLEBORUS NIGER, HYOSCYAMUS NIGER, MANDRAGORA) LIQUID [RUBIMED AG]2Current NDC, Legacy NDC, 1 package rows20241201_84440192-b3e1-4210-a07b-7471e77de1c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66343-115-606634301156060 mL in 1 BOTTLE (66343-115-60) 60 ml2022-12-230000-00-00NoNoCurrent